A Study Testing the Effect of Immunotherapy (Ipilimumab and Nivolumab) in Patients With Recurrent Glioma With Elevated Mutational Burden

StatusActive, Not Recruiting
PhasePhase 2
Started

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Trial flagged as At Risk
Primary completion moved at least 6 months later Dec 31, 2026 → Jun 30, 2027
See other at-risk trials from National Cancer Institute (NCI)

Record History

The 50 most recent of 353 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Dec 31, 2026 to Jun 30, 2027
    • Eligibility criteria shortened, about 37 words
    • Secondary endpoints: details revised at 3 of 3 entries
    • Site details revised at 24 of 414 sites
  2. Re-verified, no change to tracked fieldsv352
  3. Study sites: 415 to 414v351
  4. Study sites revised (415)v350
  5. Study sites revised (415)v349
Show 45 earlier versionsHide 45 earlier versions
  1. Study sites: 416 to 415v348
  2. Study sites revised (416)v347
  3. Study sites revised (416)v346
  4. 28 versions Re-verified since Mar 3, 2026, no change to tracked fieldsv318-v345
  5. Primary and study completion dates: May 31, 2026 to Dec 31, 2026v317
  6. 2 versions Re-verified since Aug 29, 2025, no change to tracked fieldsv315-v316
  7. Study sites revised (416)v314
  8. Trial status: Suspended to Active, Not Recruiting
    • Primary and study completion dates: May 31, 2025 to May 31, 2026
    • Study sites revised (416)
    v313
  9. 7 versions Re-verified since Mar 26, 2025, no change to tracked fieldsv306-v312
  10. Study sites revised (416)v305
  11. Study sites revised (416)v304
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This phase II trial studies the effect of immunotherapy drugs (ipilimumab and nivolumab) in treating patients with glioma that has come back (recurrent) and carries a high number of mutations (mutational burden). Cancer is caused by changes (mutations) to genes that control the way cells function. Tumors with high number of mutations may respond well to immunotherapy. Immunotherapy with monoclonal antibodies such as ipilimumab and nivolumab may help the body's immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread. Giving ipilimumab and nivolumab may lower the chance of recurrent glioblastoma with high number of mutations from growing or spreading compared to usual care (surgery or chemotherapy).
Trial Details
NCT Number NCT04145115
Lead Sponsor National Cancer Institute (NCI)
Conditions
(from sponsor)		 Astrocytoma, IDH-Mutant, Grade 4, Diffuse Glioma, Glioblastoma, IDH-Wildtype, Secondary Glioblastoma
Related terms Astrocytoma, Glioblastoma
Enrollment 37 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov